Ensituximab Explained

Ensituximab (NPC-1C) is a chimeric monoclonal antibody under development for as a candidate for treatment of cancers.[1] The target of the antibody is uncertain and is described as "human colorectal and pancreatic carcinoma-associated antigens", a set of tumor antigens isolated from human cancers.[2] The target might be Mucin 5AC.[3]

The antibody was discovered by scientists at Neogenix Oncology using tumor antigens that had been identified years earlier by Ariel Hollinshead; the founder of Neogenix had founded a prior company based on Hollinshead's work as well.[4] Neogenix worked with Selexis to develop the CHO cell line expressing ensituximab[5] [6] and also worked with Goodwin Biotechnology Inc on process development.[7]

Ensituximab was granted orphan drug designation for pancreatic cancer by the FDA in 2010.[8]

In 2011 Neogenix was forced to declare bankruptcy because the SEC opened an investigation into its use of unregistered broker-dealers in the course of raising $30M, and it could not raise further funds; in 2012 Neogenix sold its assets to a group of its investors who had formed a company called Precision Biologics.[9]

In 2016, Precision released data from a Phase II trial colorectal cancer and at that time was working with Cytovance Biologics as its contract manufacturing organization.[10]

Notes and References

  1. Web site: Statement On A Nonproprietary Name Adopted By The USAN Council: Ensituximab. American Medical Association.
  2. Web site: Ensituximab. NCI Drug Dictionary. 31 January 2017. en.
  3. Kim RD, Azad NS, Morse MA, Poplin E, Mahipal A, Tan B, Mavroukakis SA, Fantini M, Tsang KY, Zaki A, Torrealba J . 6 . Phase II Study of Ensituximab, a Novel Chimeric Monoclonal Antibody, in Adults with Unresectable, Metastatic Colorectal Cancer. Clinical Cancer Research. 26. 14. 2020. 3557–3564. 1078-0432. 10.1158/1078-0432.CCR-20-0426. 32303539 . 215809528 . free.
  4. News: Morrison . Trista . vanc . Neogenix Uses Cancer Vaccine And Antibody Approaches. BioWorld Today. July 11, 2007.
  5. Neogenix Oncology, Inc. - Pharmaceuticals & healthcare - Deals and alliances profile. (2015). London: Global Data Ltd.
  6. Web site: Press ReleaseL Selexis and Neogenix Oncology Execute Commercial License Agreement - Selexis SA. Selexis SA. 5 January 2011.
  7. Web site: From Vaccines To Monoclonal Antibodies: Creating Milestones In Cancer Theranostics. Frost & Sullivan. 14 September 2007.
  8. News: Staff. FDA Pipeline Preview, December 2010 (Ezogabine, Solesta, Dutasteride, Finasteride, Octaplex, SF1126, MP4CO, Ensituximab, Naloxone, CBLB502). Formulary Journal. 1 December 2010. en. 31 January 2017. https://web.archive.org/web/20170202093804/http://formularyjournal.modernmedicine.com/formulary-journal/news/clinical/clinical-pharmacology/fda-pipeline-preview-december-2010-ezogabine-s. 2 February 2017. dead.
  9. News: Davie. Alexander J. . vanc . Neogenix Oncology: A Good Case Study on Securities Law (Non)Compliance by a High Growth Company – Part 1: How It All Happened. Strictly Business. 5 October 2012. . News: Neogenix Oncology: A Good Case Study on Securities Law (Non)Compliance by a High Growth Company – Part 2: What Neogenix Did. Strictly Business. 24 October 2012. . News: Neogenix Oncology: A Good Case Study on Securities Law (Non)Compliance by a High Growth Company – Part 3: When the Genie Can't Be Put Back in the Bottle. Strictly Business. 17 November 2012.
  10. Web site: Ensituximab - Precision Biologics . Adis Insight . Springer Nature Switzerland AG . 30 January 2017 .

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